The intended use of Redyrob is as a vacuum source / waste container utilized for post operative wound drainage. The indications for use for the device are to drain blood and secretions from wounds and body cavities for hematoma and surtma prophylaxes and for the removal of serosanguineous fluid and other harmful liquids.

Device Description

REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.

AI/ML Overview

The provided text describes a 510(k) submission for the REDYROB® Closed Wound Drainage System. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing new performance metrics or acceptance criteria as one might find for a novel, high-risk device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a Class I device of this nature. The "acceptance criteria" here primarily refer to the product meeting its design specifications and demonstrating suitability through material testing and physical testing, rather than clinical performance metrics.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Safety	Biocompatibility in accordance with ISO Standard 10993.	Materials "have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product."
Product Release	Meet all required release specifications (physical testing, visual examination).	"All finished products are tested and must meet all required release specifications before distribution." "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)." "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."
Substantial Equivalence	Similar intended use as predicate device (Varidyne Model 250 Suction Drainage System). No new issues of safety or effectiveness.	REDYROB® "is similar in intended use to the Varidyne Model 250 Suction Drainage System manufactured by Surgidyne. There are no new issues of safety or effectiveness raised by REDYROB® Closed Wound Drainage System."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified for material or physical testing. The context implies routine quality control testing of manufactured units, which would involve a representative sample size based on manufacturing volumes and statistical sampling plans, but the specific numbers are not provided in this regulatory summary.
Data Provenance: Not explicitly stated regarding country of origin for testing data. The testing is described as occurring internally by B. Braun Medical, Inc. (USA-based company). The testing is retrospective, as it's part of post-manufacturing quality control and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable in the context of this 510(k) summary. The "ground truth" for the device's technical performance is based on internal quality control standards and specifications, not expert clinical diagnosis or interpretation.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth for a diagnostic device. Here, the "truth" is whether a manufactured unit meets its engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device, nor is it a device that involves human readers or interpretation of results in that sense. It is a physical medical device (a wound drainage system).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The REDYROB® is a physical device, not an algorithm.

7. The Type of Ground Truth Used:

For material safety, the ground truth is established by ISO Standard 10993 requirements for biocompatibility.
For product performance, the ground truth is established by product design specifications, quality control test procedure documents, and established testing parameters. This is based on engineering and manufacturing standards.
For substantial equivalence, the ground truth is the performance and safety profile of the legally marketed predicate device (Varidyne Model 250 Suction Drainage System).

8. The Sample Size for the Training Set:

Not applicable. This document does not describe the development of a predictive model or algorithm that would require a training set. The device is a physically manufactured product.

9. How the Ground Truth for the Training Set was Established:

Not applicable for the same reason as above. There is no training set for this type of device.

Summary

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K972703

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

OCT - 1 1997

July 10, 1997

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400

Mark S. Alsberge, Requlatory Affairs Manager Contact:

REDYROB ® Closed Wound Drainage System Product Name:

Apparatus, Suction, Single Patient Use, Portable, Nonpowered Trade Name:

Classification name:

General Hospital and Plastic Surgery Class :1. - 79 GCY 21 CRF 878.4680

SUBSTANTIAL EQUIVALENCE1 TO:

510(k) number	Name	Applicant
K883582	Varidyne Model 250 SuctionDrainage System	Surgidyne

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce REDYROB ®, Closed Wound Drainage System. REDYROB ® is a vacuum source/waste container utilized for postoperative wound drainage.

1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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Material:

REDYROB ® is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.

Substantial equivalence:

REDYROB ® is similar in intended use to the Varidyne Model 250 Suction Drainage System manufactured by Surgidyne. There are no new issues of safety or effectiveness raised by REDYROB ® Closed Wound Drainage System.

Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approve', released, distributed and revised in accordance with document control CGMP's.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 1 1997

Mr. Mark S. Alsberge .Regulatory Affairs Director B. Braun Medical, Inc. 824 Twelfth Avenue Bethlehem, Pennsylvania 18018-0027

Re: K972703

Trade Name: REDYROB® Closed Wound Drainage System Regulatory Class: I Product Code: GCY Dated: July 17, 1997 Received: July 18, 1997

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Mark S. Alsberge

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

palla

lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Dramage Redyrob - Closed Woung Device Name: oum Indications For Use:

The intended use of Redyrob is
as a vacuum source / waste container
utilized for post operative wound
drainage. The indications for use
for the device are to drain blood
and secretions from wounds and
body cavities for hematoma and
surtma prophylaxes and for the
removal of serosanguineous fluid
and other harmful liquids.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

loach

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K972703

Prescription Use (Pcr 21 CFR 801.109)

Over-The-Counter Use .

(Optional Forrant 1-2-96)

Regulation Number and Section

§ 878.4680 Nonpowered, single patient, portable suction apparatus.

(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.